Job Title: Bioanalytical Senior Principal Scientist
About the Role
We are seeking a highly experienced and skilled Bioanalytical Senior Principal Scientist to join our team on a permanent basis.
As a Bioanalytical Senior Principal Scientist in Quality Control, you will provide analytical leadership for all aspects of bioanalytical technologies and methods.
Key Responsibilities
* Lead the introduction, validation, and ongoing technical agenda for pipeline and commercial analytical methods and technology
* Develop and validate robust scientifically advanced methods with the required performance attributes to satisfy stakeholder needs
* Execute and/or oversee testing protocols in accordance with biosafety, local procedure, and regulatory requirements
* Develop strong links with Global Regulatory Affairs and participate in the preparation and review of regulatory submissions
* Develop strong links with Bioproducts Research and Development and participate in the development and transfer of new techniques and methodologies
* Develop strong links with other manufacturing sites to deliver their support needs
* Provide training or mentorship to other QC or cross-functional team members as required
* Act as SME for molecular and chromatographic based analytical technologies
Additional Responsibilities
* Identify, source, install, and qualify new equipment as required
* Ensure that all samples are appropriately received, stored, analyzed, and disposed of accordingly
* Test outsourced to third parties when necessary
* In the event of non-conformance to acceptable quality and/or safety standards, lead and document analytical investigations using Root Cause Analysis techniques where appropriate
* Implement countermeasures to address any issues identified
* Stay up-to-date with relevant scientific literature, new technologies/capabilities, and regulatory initiatives/requirements
* Support the implementation of new technologies and capabilities
* Contribute to the writing of Annual Product Reviews (APRs) and Laboratory Periodic Review Reports (PRRs)
* Participate in self-inspection or other audits with particular reference to the analytical aspects of cGMPs as defined by the Health Authorities, and Food and Drug Administration Requirements
Requirements:
* BSc/MSc/PhD in Biochemistry, Molecular Biology, Cellular Biology, Biology, or related field
* Minimum 7 years of recent experience, preferably in a QC laboratory environment
* Experience with molecular testing, such as ELISA assays, qPCR assays
* Experience with separation testing, such as HPLC, UPLC, CE, iCEIF assays
* Strong written and oral communication skills
* Ability to work independently, self-sufficiently, and proactively in the performance of work duties
* Ability to resolve conflict and promote good decision-making among team members
* High learning agility and flexibility to achieve the required outcomes
* Imaginative approach to problem-solving and solution discovery